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Predictive Factors Study (TAPAS)

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ClinicalTrials.gov Identifier: NCT02020499
Recruitment Status : Terminated (Poor enrolment)
First Posted : December 25, 2013
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.

Condition or disease Intervention/treatment
Acromegaly Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.

Study Design
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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.
Study Start Date : August 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Acromegalic patients
Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)
 Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline [ Time Frame: Baseline and 4 weeks ]

Secondary Outcome Measures :
  1. Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline [ Time Frame: Baseline, 1 year and 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects in hospitals and private practices, suffering from acromegaly who are scheduled to receive ATG or already on treatment with ATG for a maximum of 3 months.
Criteria

Inclusion Criteria:

  • Diagnosis of Acromegaly.
  • Males and females aged 18 years and older.
  • Signed informed consent (patient must give consent to the collection of retrospective data).
  • Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study.
  • With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG.
  • If already being treated with ATG:

Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable).

  • Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly.

Exclusion Criteria:

  • The subject has had radiotherapy in the last 5 years.
  • The subject has had surgery in the last 3 months.
  • The subject has already been included in this study.
  • Participation in an interventional trial, or receiving experimental drug.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020499


Locations
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Australia, New South Wales
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4006
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
St Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
The Austin Hospital
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02020499    
Other Study ID Numbers: A-9B-52030-265
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents